FDA Regulatory Education for Industry (REdI) Conference Fall 2015 Presentation Slides
Day 1 - General Session - September 29, 2015
Day 1 - Drugs Track - September 29, 2015
- Safety Considerations for Product Design, Container Labels, and Carton Labeling and Best Practices in Developing Proprietary Names for Drugs
- Good Clinical Practice (GCP) Inspectional Perspective on Use of Electronic Records and Signatures in Clinical Trials
- Comparing Safety Report Requirements for Pre and Post Market
- Pediatric Drug Development: Regulatory Expectations
- Clinical Outcome Assessment Implementation in Clinical Trials
Day 1 - Devices Track - September 29, 2015
- Device Classification Overview
- Device Clinical Trials and the IDE Program - Fall 2015
- The 510(k) Program - Fall 2015
- Labeling Overview
Day 2 - Drugs Track - September 30, 2015
- Overview of FDA Expedited Programs with a Focus on the Breakthrough Therapy
- FDA's Pre-Approval Inspection (PAI) Program and How to prepare for a successful outcome
- CDER Regulatory Applications - Investigational New Drug and New Drug Applications
- Lifecycle Management of Drug Products: FDAâs Perspective
- Lifecycle Management of Drug Products
- Evidence and Data Requirements for NDA Submissions
- Demystifying Interactions with FDA-CDER: A Primer on Formal Meetings and Best Practices
Day 2 - Devices Track - September 30, 2015
- Welcome
- Overview of Quality Systems Regulation
- Design Controls - Devices
- Purchasing Controls - Devices
- Process Validation
- Unique Device Identification (UDI) - Fall 2015
- FDA Medical Device Inspections - Fall 2015